Modification is required when an investigator wishes to implement a change to a project which constitutes a deviation from what was approved in the initial IRB Research Application and/or accompanying materials. Changes are classified as either major or minor .
Minor changes include those changes to the project that have no impact on the primary goals of the research or procedures detailed in the initial application and which do not significantly increase or change the risks associated with participation in the research.
Major changes include those changes to the project that significantly alter the goals or protocols described in the initial research application or which pose potential harms to human participants beyond or different from what was originally approved.
Examples of both minor/major changes may include but are not limited to:
|Minor Changes||Major Changes|
The review process for major changes may take between one and five weeks depending on the reviewers’ schedules and the nature of the modification (between 5 and 25 business days).